Abstract:

Telescopic guide device (7) with an adapter (10), for mounting on
catheters (E) to facilitate their insertion and movement in the human
cardiovascular system by a manual procedure or by means of a robotic
manipulator, characterized in that the telescopic guide assembly (7) is
provided at its other end with an adapter means having a friction
coupling (1, 101, 201, 201', 301, 2, 3, 4), to be mounted on the proximal
portion of the catheter which is connected to the handle (M) of the
catheter, in such a way that it can be associated with catheters made by
different manufacturers and also with catheters having different
diameters which lie within a wide range of values.

Claims:

1. Telescopic guide device (7) with an adapter (10), for mounting on
catheters (E) to facilitate their insertion and movement in the human
cardiovascular system by a manual procedure or by means of a robotic
manipulator, characterized in that the telescopic guide assembly (7) is
provided at its other end with an adapter means having a friction
coupling (1, 101, 201, 201', 301, 2, 3, 4), to be mounted on the proximal
portion of the catheter which is connected to the handle (M) of the
catheter, in such a way that it can be associated with catheters made by
different manufacturers and also with catheters having different
diameters which lie within a wide range of values.

2. Device according to claim 1, in which said adapter means with a
friction coupling (1) is connected to the telescopic guide (7) by means
of a short jointed guide formed for example by a flexible tube (5).

3. Device according to claim 2, in which said flexible tube (5) is
transparent, thus revealing the passage of the catheter through it.

4. Device according to claim 1, in which the telescopic guide (7) is
formed by more than two sections, for example three sections (107, 207,
307).

5. Device according to claim 4, in which the telescopic guide (7)
comprises said telescopic sections (107, 207, 307) and comprises a first
coupling (6) to be fixed on the end of the outer section (107) which is
to be connected to said jointed guide (5) and comprises a second coupling
(8) to be fixed on the outer end of the inner section (307) and to be
fixed indirectly to the adapter (10), the body of this second coupling
(8) having a length such that it can be fitted with a sufficient degree
of friction into the free end of the outer section (107) of the guide, so
as to stabilize the telescopic guide (7) in the closed position.

6. Device according to claim 5, in which said second end coupling (8) of
the telescopic guide (7) is fixed to the adapter (10) with the
interposition of a small unit (9) for braking the catheter, provided with
a flexible sheath (13) through which the catheter passes and provided
with rapid actuating means (15) which can be moved from a rest position
to a position in which they flatten said sheath on to the catheter inside
it, in order to brake the catheter gently in the desired position.

7. Device according to claim 6, in which said rapid actuating means are
rotary means (15, 115, 215, 16, 116).

Description:

[0001]There is a known way of inserting flexible catheters into the
cardiovascular system of the human body for diagnostic and/or therapeutic
purposes, the catheters being, for example, of the type illustrated in
FIG. 1 of the appended drawings, each catheter being provided with a
robust handle M whose front end M1 is fixed to the catheter E and whose
rear end carries a connector C for connection to the diagnostic
instruments. If required, an annular slider A can be made to slide in
both directions on this handle, thus causing the deflection of the distal
end E1 of the catheter by means of known connections inside the catheter,
as indicated in broken lines in FIG. 1, to produce the deflection
manoeuvres required during the insertion of the catheter into the human
cardiovascular system and its removal therefrom. In normal use,
appropriate movements are imparted to the handle M to make the catheter
advance or withdraw by axial movements or rotate about its axis in both
directions, and furthermore, as mentioned above, if said slider A is
present it can be operated to subject the catheter, if required, to an
operation of deflection or steering of its distal end which is usually
provided with one or more electrodes Z. To facilitate the maneuvering of
a catheter according to the example of FIG. 1, there is a known way of
using an insertion and adaptation device as described in Italian patent
1363313 and in European publication No. 2 218 474 and corresponding US
Application No. US-2010-0204680-A1, to which ample reference will be
made. This device comprises a telescopic guide which is to be mounted on
the catheter in advance, one end of this guide being designed for
coupling to the end M1 of the catheter handle as shown in the example of
FIG. 1, while its other end is coupled to the introduction device whose
cannula has previously been inserted into the patient's artery or vein,
with the interposition of an adapter means which is fitted in a sealed
way into the resilient seal of the introduction device and which carries
its own sealing means for calibrated interaction with the diameter of the
catheter, in such a way that the catheter can be made to slide and can
rotate with a low degree of friction through the adaptation and
introduction unit, while the portion of catheter lying between said unit
and the handle M is kept rigid by said telescopic guide and is therefore
in the optimal condition for reacting to the commands imparted to it
through the handle M.

[0002]The known device to which reference is made presents difficulties in
the coupling of the telescopic guide to the handle M, since, for any
given outside diameter of the catheter E, the shape and dimensions of the
front end M1 of the handle M may vary from one manufacturer to another.
Another limitation of the known device is that the coupling between the
telescopic guide and the handle M of the catheter is such that the two
parts form a single rigid body, and this condition gives rise to
difficulties in the positioning and manoeuvring of the catheter.

[0003]In a preferred embodiment of the known device, the telescopic guide
is formed by only two sections, and therefore the guide is excessively
long when in its closed position, which complicates the packaging of the
device in a sterile package and also complicates the use of the device.

[0004]Another limitation of the known device arises from the lack of
reliability and security of the male and female screw means which is
proposed for axially locking the catheter with respect to said adapter,
since the activation and inactivation of this screw means takes a
considerable time, and the screw means also acts directly in contact with
the catheter, with the risk of damaging it.

[0005]The object of the invention is to overcome all of these and other
problems and limitations of the prior art with an improved device as
claimed in Claim 1 and in the subsequent dependent claims, the features
and advantages of this device being made evident by the following
description which refers to the figures of the three appended sheets of
drawings, in which, in addition to FIG. 1 which has already been
described,

[0006]FIG. 2 is a perspective view of the device in use, with the catheter
being inserted into the cardiovascular system of a patient;

[0007]FIGS. 3 and 4 show the device from above and from the side, with
parts shown in section and with the telescopic guide shown in the closed
position in which it is taken from the sterile packaging;

[0008]FIGS. 5 and 6 show in side view, with parts in section, the part of
the device with the adapter and the axial catheter locking means, in the
rest position and in the working position respectively;

[0009]FIG. 7 is a perspective view of the rotating stopping member of the
locking means of FIGS. 5 and 6.

[0010]FIGS. 2, 3 and 4 show that the novel device comprises a first unit 1
for fixing the device directly to the first portion of the catheter which
extends from the handle M, this unit comprising a small boxlike body 101
with a small hollow coupling member 201 at one end, with an axial
aperture 2 at the other end, and containing a body 301 made from suitable
elastomeric material, having central recessed indentations 3 on its
opposite faces and having a diametrically located flat or shaped
penetrating slit 4 in the portions where these indentations are present,
through which the catheter E can be inserted with a friction fit until
the unit 1 reaches the end M1 of the handle M, as shown by way of example
in FIG. 3, in such a way that the unit is in contact with a portion of
the catheter which executes no bending movements and on which the unit 1
remains in a stable way and in axial alignment as a result of the
friction fit. The diameter of the axial cavity of the coupling member 201
and the dimensions of the slit 4 are such that the unit 1 can be
positioned on catheters whose outside diameter lies within a wide range
of values and on catheters having handles M of any shape or size, thus
yielding benefits in terms of practicality and economy.

[0011]The coupling member 201 terminates in an enlarged edge with a curved
profile 201', in such a way that the end of a tube 5, made from silicone
rubber for example and preferably transparent to reveal the passage and
movement of the catheter, can be frictionally fitted in a sealed way on
to the coupling member, while its opposite end is frictionally connected
in a sealed way to a similar coupling member 6 fixed to one end of the
telescopic guide 7 which is described more fully below, the whole
arrangement being such that, before reaching this guide 7, the catheter
slides in a guided way in the flexible tube 5 which acts as a joint
between the unit 1 and the guide 7, in order to allow greater freedom in
the positioning of the catheter handle M and to prevent the direct
transmission of small movements, which are imparted to the handle but
which are not necessary for the operation of the catheter, to the guide 7
and to the downstream devices or to the patient P, which may occur in the
prior art.

[0012]A further improvement made to the device is that the telescopic
guide 7 is made with more than two telescopic sections, for example with
three sections as in the example shown in FIG. 4, in such a way that,
when at rest with the three sections retracted into each other, the guide
is shorter than a guide with two sections which have a similar length
when extended, since the length in the closed condition is substantially
equal to the length of the guide in the extended condition divided by the
number of telescopic sections that make up the guide. FIG. 4 shows that
the aforesaid coupling member 6 is fixed to one end of the outer section
107 of the guide 7 and that the coupling extends slightly into this
section so as to halt the contraction of the intermediate section 207
which has an outer enlarged area 207' which is halted in the course of
extension when it encounters the inner enlarged area 107' of the outer
section 107. The intermediate section is also provided at its other end
with an inner enlarged area 207'' which acts as a stop on the outer
enlarged area 307' of the inner section 307 which has a coupling 8 fixed
on its outer end and formed from opposing coupling members, through which
the catheter can pass axially, while the other end of the coupling is
fixed to the body of the catheter braking unit 9 whose opposite face is
fixed to the known adapter 10 which was mentioned in the preamble.

[0013]Advantageously, the outside diameter of the body of the coupling 8
is such that the distal end of the outer section 107 of the guide 7 can
be frictionally fitted on to this body, in such a way that the guide
remains stably in the closed position when the device is removed from the
packaging, in order to facilitate the application of the device. In the
telescopic guide 7 as shown in FIG. 4, the inner sections 207 and 307 are
mounted in the outer section 107 from the end of this section which is
temporarily free of the coupling 6 which is applied and fixed
subsequently. When the three sections have been coupled together, the
coupling 8 is applied and fixed to the outer end of the section 307, and
thus the guide is substantially formed by at least five parts. However,
it is to be understood that the construction of the telescopic guide 7
can be varied and modified in numerous ways without departing from the
protective scope of the invention.

[0014]FIGS. 3, 4 and 5 show that the braking unit 9 comprises a body 109
pierced longitudinally by a hole which has, for example, a portion of
smaller diameter 11 which can be engaged by one of the end coupling
members of the coupling 8, a tube 13 of suitable plastic material, such
as silicone rubber, being initially inserted into the remaining portion
12 of said hole and being stopped by the step formed by the hole 11,
after which the coupling member 110 of the adapter 10 is inserted and
fixed. The inside diameter of the tube 13 is made suitably larger than
the outside diameter of the catheter. The body 109 has a hole 14 running
perpendicularly to the intermediate part of the portion of the hole 12
occupied by the tube 13, the hole 14 being rotatably engaged by a barrel
15 having a head 115 and a radial lever 215 which remain outside said
body 109. On its lower end the barrel 15 has a recess 16, in the form of
a sector of a circle for example, the generatrix of which is parallel to
the longitudinal axis of the lever 215, such that, when this lever is
aligned longitudinally with the guide 7, as shown in solid lines in FIGS.
3, 4 and 5, said recess 16 is positioned longitudinally above the tube
13, substantially without deformation of the latter, while the end
appendages 116 of the recess 16 are placed at the sides of the tube 13
and are characterized in that they have suitably rounded edges.

[0015]FIG. 3 shows that the head 115 of the barrel 15 is provided,
laterally and over its whole height, with a flat 17 which reduces its
diameter and which, during the assembly of the unit 9, when the barrel is
inserted into its seat 14, is positioned parallel to and on the same side
as a cam 18 in the shape of an L rotated through 90°, which is
fixed to the body 109, in such a way that, when the lever 215 is
subsequently rotated into alignment with the holes 11 and 12, the head
115 of the barrel is positioned under the upper arm of said cam 18, thus
keeping the barrel 15 stably in position. When the barrel 15 has been
fitted, a stop pin 19 is positioned and fixed in a suitable seat in the
body 109, said lever 215 bearing on this pin when it is in said
longitudinal orientation in which it does not flatten the rubber tube 13,
thus leaving the catheter free to slide through the unit 9 and through
the upstream units 1 and 7 and the downstream unit 10. If the operator
rotates the lever 215 through 90°, the lever is positioned under
the arm of the cam 18, which contributes to the axial retention of the
barrel 15 in position, since, as a result of this rotation, the lateral
appendages 116 of the end recess 16 of the barrel press on the tube 13
flatten it as shown in FIG. 6, and this flattening of the tube 13 gently
locks the catheter E and prevents it from moving in an undesirable way in
relation to all the components of the device in question. It is to be
understood that the scope of the invention also covers solutions
different from that which has been described for achieving the flattening
of the tube 13, for example the use of rocking control means which, with
the assistance of resilient means, enable the position of the barrel or
stopping member 15 to be modified in its seat 14.

[0016]The adapter 10 is of the type fully described in the prior patents
cited in the preamble and is provided with a bayonet fitting 210 for
rapid connection to the introduction device I of FIG. 2 and with an axial
nozzle 310, from which the catheter E emerges by a sliding movement, and
which is designed to be coupled to the seal of the introduction device I,
which is not illustrated in detail since it is a known means.

[0017]All the components of the device are made from non-toxic materials,
which are compatible with the use for which the device is intended and
can be easily sterilized.